🇺🇸
United States · US · US:16729-485_4e68b971-e226-d3ff-e063-6294a90ae772
Hydroxychloroquine Sulfate
In shortageOrange BookUNIISPLATC P01BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.,
CountryUS (United States)
ATC codeP01BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111672948501100 TABLET in 1 BOTTLE (16729-485-01)
- ndc111672948516500 TABLET in 1 BOTTLE (16729-485-16)
Annotations
UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A213342
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydroxychloroquine Sulfate Tablet
Raw payload (JSON)
{
"unii": {
"unii": "8Q2869CNVH",
"rxcui": "153972",
"inchikey": "JCBIVZZPXRZKTI-UHFFFAOYSA-N",
"display_name": "HYDROXYCHLOROQUINE SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6971241c-8323-456e-91a4-a404a9e100de": {
"match": "brand_token",
"title": "HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "16",
"published_date": "2026-06-01"
}
},
"productid": "16729-485_4e68b971-e226-d3ff-e063-6294a90ae772",
"productndc": "16729-485",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213342",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Apr 7, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Aug 18, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Aug 18, 2021"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "004",
"approval_date": "Aug 18, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYCHLOROQUINE SULFATE",
"shortage_reason": "Hydroxychloroquine Sulfate Tablet",
"shortage_status": "current",
"proprietary_name": "Hydroxychloroquine Sulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213342",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxychloroquine Sulfate",
"start_marketing_date": "20200512",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code P01BA02.
- CAAPO-HYDROXYQUINEAPOTEX INC
- PLAutokilaTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
- FIErcoquinOrion Pharma A/S
- 🇪🇸HIDROXICLOROQUINA ACCORD 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAccord Healthcare S.L.U.
- 🇪🇸HIDROXICLOROQUINA ALDO-UNION 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorio Aldo Union S.L.
- 🇪🇸HIDROXICLOROQUINA ARISTO 200 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFGAristo Pharma Gmbh
- 🇪🇸HIDROXICLOROQUINA AUROVITAS 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAurovitas Spain, S.A.U.
- 🇪🇸HIDROXICLOROQUINA RUBIO 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorios Rubio S.A.
Access this data programmatically
Query Hydroxychloroquine Sulfate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.